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Session 3, Part II: Roundtable on Opportunities to Optimize the Post-approval System
Session Chair(s)
Lina Cacic, MSc
Principal Advisor for Regulatory Affairs
Croatian Agency For Medicinal Products and Medical Devices (HALMED), Croatia (Hrvatska)
The panel discussion will focus on the future outlook and opportunities for the evolution of variation system to benefit of patients and regulatory operations.
Speaker(s)
Representing AKBPM, Albania
Ranela Ceci, PhD
National Agency For Medicinal Products and Medical Devices (AKBPM), Albania
Specialist, Marketing Authorization and Regulatory Affairs Department
Representing AKPPM, Kosovo
Sulltane Havolli, MBA, MPharm
Kosovo Medicines Agency (AKPPM), Kosovo
Senior Review Officer
Representing ALMBiH, Bosnia and Herzegovina
Biljana Tubic, DrSc
Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina
Deputy Agency Director for the Department for Medicinal Products for Human Use
Representing CALIMS, Montenegro
Milena Lješkovic
Agency for Medicines and Medical Devices of Montenegro, Montenegro
Head of Department for Marketing Authorisation
Representing MALMED, North Macedonia
Elona Chilku
Agency for Medicines and Medical Devices of Macedonia (MALMED), North Macedonia
Representing WHO
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
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